Intarcia Therapeutics, Inc. Announces Completion of Enrollment of ITCA 650 Phase 1b Study for the Treatment of Type 2 Diabetes
First study evaluating DUROS(R) continuous delivery of exenatide for the treatment of type 2 diabetes
HAYWARD, Calif., April 24 /PRNewswire/ -- Intarcia Therapeutics, Inc. today announced the completion of patient accrual to a phase 1b clinical study evaluating ITCA 650 (DUROS(R) continuous delivery of exenatide). The study is being conducted at multiple centers in the United States and involves the treatment of 44 patients with type 2 diabetes for a period of 4 weeks.
Intarcia began the development of ITCA 650 in 2007 after acquiring an exclusive worldwide license to the DUROS delivery technology. The DUROS delivery technology consists of the DUROS device, a matchstick-size miniature osmotic pump that is inserted subcutaneously to provide continuous and consistent drug therapy, and proprietary formulation technology that maintains stability of therapeutic proteins and peptides at human body temperature for extended periods of time. Exenatide, the active agent in ITCA 650, has been approved in the US, Europe and many other markets and is currently marketed as a twice-daily self-injection therapy for type 2 diabetes.
Intarcia's phase 1 study is evaluating the safety and pharmacokinetics of ITCA 650 at several doses over a treatment period of 4 weeks. ITCA 650 therapy is administered for the full course of therapy with a single insertion of the DUROS device on day 1 and removal on day 29. Results of the phase 1 study will support selection of doses to be evaluated in a controlled phase 2 study planned for later in 2009 in which longer durations of treatment with a single ITCA 650 insertion will be evaluated. The DUROS technology can deliver up to a full year of therapy from a single ITCA 650 insertion. The goals of the ITCA 650 program are to enhance the therapeutic effects of exenatide by ensuring patient compliance and providing more consistent, round-the-clock therapeutic drug levels; and to reduce side effects, including nausea, associated with high peak levels of exenatide exposure observed with injection administration. Unlike other extended delivery technologies such as polymers or albumin fusion, DUROS delivery allows for steady state drug delivery upon insertion and near immediate withdrawal of therapy to manage side effects, if required.
"We are very pleased with the rapid progress the Company has made with ITCA 650," said Alice Leung, President & CEO of Intarcia. "Our team has demonstrated the great potential for DUROS delivered therapies in advancing this important treatment candidate for type 2 diabetes patients from an idea to clinical stage development in 18 months."
ITCA 650 is the second DUROS delivery program Intarcia has moved into clinical development. In December 2008, Intarcia also completed enrollment of a phase 1b study for ITCA 638, which involves DUROS delivery of omega interferon for the treatment of chronic hepatitis C infection. "Many patients with type 2 diabetes are forced to manage dosing schedules and side effects of multiple drug therapies simultaneously to adequately control their disease," commented Ken Luskey, M.D., VP, Clinical Research at Intarcia. "We believe ITCA 650 will deliver improved glycemic control and provide a better tolerated, more convenient treatment option."
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to ensure enhanced treatment outcome by optimizing patient adherence and improving the convenience and tolerability of drug therapies. Intarcia's drug development expertise and competitive edge are demonstrated by its abilities to stabilize proteins and peptides at above body temperature and to deliver them in a constant and consistent manner via the proprietary DUROS drug delivery platform. Intarcia is pursuing clinical stage development programs for hepatitis C and type 2 diabetes.
Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc. DUROS is a registered trademark of ALZA Corporation licensed to Intarcia Therapeutics, Inc. in certain fields.
CONTACT: James Ahlers of Intarcia Therapeutics, Inc., +1-510-782-7800,
Web site: http://www.intarcia.com/